Kornimate/medical-research-clean huggingface dataset:
oral prophylactic measures on the occurrence of pre-eclampsia (op-pe)

Conditions: Pregnancy Complications

Summary: pre-eclampsia (pe) remains a major source of maternal and perinatal morbidity and mortality especially in low- and middle-income settings. pe, a pregnancy-specific hypertensive disorder, characterized by the development of placental endothelial dysfunction resulting in, among the most common diagnostic features, concomitant hypertension and proteinuria that may evolve into organs with fluctuating clinical specificities. current studies indicate that periodontal disorders during pregnancy and particularly periodontal pathogens may be related to the risk of pe. standard oral hygiene methods, based mainly on the joint use of toothbrushes and interdental brushes, reduce periodontal inflammatory risk, modulate of the dysbiotic oral microbiome. the purpose of the present study is to compare the pe outcomes in high-risk pregnant women receiving oral prophylactic measures to a control group. one specific question is addressed as follows according to the pico principles: in high-risk pregnant women (population), does oral prophylactic measures (intervention) have a beneficial effect on pe parameters (outcome) compared to pregnant women without any specific oral prophylactic measures (control)?


Eligibility criteria:
inclusion criteria: * pregnant woman * women from sub-saharan africa * aged from 18 to 35 years old * nullipares at the time of the obstetrical consultation * up to 12 weeks pregnant * acceptance of the terms and conditions of the study * signature of the informed consent form, exclusion criteria: * fetal distress * congenital uterine and vaginal abnormalities * infectious or systemic diseases such as hiv, tuberculosis, candidiasis, cancers, hemopathies * premature termination of pregnancy for medical reasons * periodontal lesions of stage ii, iii (i.e., pd ≥ 4 mm, and/or cal ≥ 4 mm), generalized (\&amp;amp;gt;30% of sites) * history or treatment of pd * a course of dental or orthodontic treatment * absence of the 4 premolar-molar pairs * less than 20 natural teeth, excluding third molars * medication affecting the gum and/or oral mucosa * regularly using interdental brushes and/or dental floss and/or mouthwash * unable to answer questions or non-cooperative.

Keywords: pre-eclampsia pregnant periodontal disease interdental microbiota
a clinical study in current medical practice of the efficacy and safety of ranibizumab 0.5mg in diabetic patients presenting a visual impairment due to macular edema

Conditions: Visual Impairment; Macular Edema

Summary: the purpose of this study is to evaluate the proportion of patients with a 10 letters gain on best corrected visual acuity (bcva) at 6 months in current medical practice.


Eligibility criteria:
inclusion criteria: * male or female patients \>18 years of age who have signed an informed consent * patients with type 1 or type 2 diabetes mellitus (according to ada or who guidelines) with hba1c not more than 10.0% at screening (visit 1). patients should be on diet, exercise, and/or pharmacological treatment for diabetes. * patients with visual impairment due to focal or diffuse dme in at least one eye * central retinal thickness on oct ≥ 250 microns in the central subfield * bcva score between 78 and 39 letters, inclusively, using etdrs-like visual acuity testing charts at a testing distance of 4 meters (approximate snellen equivalent of 20/32 to 20/160) * decrease in vision is due to dme and not due to other causes, in the opinion of the investigator * medication for the management of diabetes must have been stable within 3 months prior to randomization and is expected to remain stable during the course of the study. exclusion criteria: ocular concomitant conditions/ diseases * concomitant conditions in the study eye which could, in the opinion of the investigator, prevent the improvement of visual acuity on study treatment * active intraocular inflammation (grade trace or above) in either eye * any active infection (e.g. conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis) in either eye * history of uveitis in either eye systemic conditions or treatments * active systemic infection * history of stroke \< 3 months * renal failure requiring dialysis or renal transplant or renal insufficiency with creatinine levels \> 2.0 mg/dl * untreated diabetes mellitus * blood pressure systolic \> 160 mmhg and diastolic \> 100 mmhg * untreated hypertension * known hypersensitivity to ranibizumab or any component of the ranibizumab formulation others * women of childbearing potential not using the contraception method(s) specified in this study (specify), as well as women who are breastfeeding other protocol-defined inclusion/exclusion criteria may apply

Keywords: visual impairment macular edema ranibizumab visual impairment due to macular edema
reconstruction of atrophic maxillary ridges using mandibular blocks with and without coverage using collagen membrane

Conditions: Bone Augmentation

Summary: is the use of collagen membrane on top of particulate bone mixture covered by onlay bone block in maxilla better than the use of mixture of particulate bone covered by onlay bone block without the use of collagen membrane, in terms of bone quality and bone quantity?

soft tissue dehiscence could result due to flap irritation as a result of, closure under tension, intraoperative or postoperative recipient site infection, postoperative edema, which in turns compromises stability of onlay bone blocks thus osseintegration of bone block. any attempt of bone recontouring and resuturing fails since there is no vascular bed. ideal requirements of barrier membranes are, they should be biological compatible, they must act as a barrier membrane, unwanted fibroblasts should be hindered from entrance while allowing diffusion of nutrients, tissue integration (biological adhesion), tissues should be able to grow into the membrane but not through it. space maintainer, it should be sufficiently stiff, so as not to collapse into the underlying particulate bone under the pressure of soft tissue and it should be ease in its manipulation, adaptation and handling, as for example, collagen membrane. some types of collagen membrane, contain some degrees of stretchability.

Eligibility criteria:
inclusion criteria: * patients with maxillary residual alveolar bone height not less than 8 mm. * alveolar bone width from less than or equal 5 mm. * both sexes. * at least missing single tooth. * previous failed implants. * previous failed grafting. exclusion criteria: * heavy smokers more than 10 cigarettes per day. * patients with alcohol abuse * patients with narcotic abuse. * patients with bone disease that may affect normal healing, example; hyperparathyroidism. * patients had radiotherapy and chemotherapy in head and neck. * patients had neoplasms in sites to be grafted. 18 * patients with metabolic diseases uncontrolled diabetic patients, glycated hemoglobin (hb a1c) more than 7 mg\\dl. * pregnant females. * patients with para functional habits, apprehensive and non-cooperative. * bone pathology related to the site to be grafted. * psychological problems, stress situation (socially or professionally), emotional instability, and unrealistic patients' expectations. * intraoral soft and hard tissue pathology. * systemic condition that contraindicate implant placement. * under the age of 18 years.
colesevelam for children with type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: this study will evaluate the efficacy and safety of the study drug in treating type 2 diabetes in children 10 to 17 years old. the groups will be low-dose (0.625 g welchol) and high-dose (3.75 g welchol). the children will have a 2 in 5 chance of being assigned to the low-dose group. they will have a 3 in 5 chance of being assigned to the high-dose group. we believe the study drug will be safe, well tolerated, and improve blood sugar control in children 10 to 17 years old.

colesevelam oral suspension will be studied as treatment of type 2 diabetes mellitus (t2dm) to evaluate clinical safety and efficacy in patients aged 10-17 years. the patients may have been treated with metformin or have had no antidiabetic drug treatment in the previous three months. study hypothesis: colesevelam oral suspension for pediatric subjects with t2dm is safe, well tolerated, and shows improved blood sugar control (as evidenced by a significant change from baseline in hemoglobin a1c \[hba1c\]).

Eligibility criteria:
inclusion criteria: * diagnosis of type 2 diabetes mellitus, as defined by the american diabetes association; * written informed consent of study participation * males and females aged 10 to 17 years, inclusive, at randomization (randomization must occur before 18th birthday); * hba1c at screening between 7.0% and 10.0%, inclusive; * fasting c-peptide \>0.6 ng/ml; and * anti-diabetic treatment at screening: * treatment-naïve or untreated; or * on metformin monotherapy: metformin monotherapy has been initiated prior to screening. exclusion criteria: * fasting plasma glucose \>270 mg/dl; * diagnosis of type 1 diabetes; * history of more than one episode of ketoacidosis after the initial diagnosis of type 2 diabetes mellitus; * clinical laboratory assessments/evaluations, eg. autoimmune markers, aminotransferases, triglycerides, creatinine clearance, and hb variants, that are not within the protocol-defined parameters * systolic blood pressure ≥150 mmhg or diastolic blood pressure ≥95 mmhg * use of medications not allowed by protocol-defined parameters, eg. insulin or any medication that affects insulin sensitivity or secretion, growth hormones/somatotropin, or anabolic steroids * genetic syndrome or disorder known to affect glucose * participation in a weight loss program or another interventional research study within 60 days; * female participants who are lactating, pregnant, or plan to become pregnant within 1 year of screening; * female participants who are sexually active and unwilling to use appropriate contraception for the duration of the study; * history of bowel obstruction; * other significant organ system illness or condition (including psychiatric or developmental disorder) that, in the opinion of the investigator, would prevent full participation

Keywords: type 2 diabetes mellitus blood glucose anti-diabetic bile acid sequestrant colesevelam hcl oral suspension pediatric add-on therapy add-on to metformin metformin adolescent lipid
questionnaire for the evaluation of anger, hostility and aggression after acquired brain injury.

Conditions: Cerebral Lesion

Summary: the incidence of aggression and violent behavior is usually reported to be high after acquired brain injury, around 54%. behaviors with verbal agression and, less frequently, physical agressions, are described. these behaviors may be linked to the dysfunction of the frontal lobes responsible for executive functions and complex social interactions, or to the dysfunction of the temporal structures that may also be responsible for increased aggression. it is interesting to note that very few scales or specific questionnaires evaluate the factors and co-variables that could lead to aggressive behavior after an acquired brain injury. such questionnaires are very rare, and none have been validated in french. the objective of this study is to develop a questionnaire in french that aims to assess anger, hostility and aggression after acquired brain injury. the psychometric qualities of this questionnaire will be evaluated using the rasch probabilistic model. the development of such a tool will be of major interest for clinical practice and future clinical research.


Eligibility criteria:
inclusion criteria: * patients of the chu brugmann hospital * central neurological pathology of vascular or traumatic origin, acute or chronic (known since more than one year). exclusion criteria: * pregnant or lactating women * presence or antecedents of psychiatric disease * degenerative pathology (ex: parkinson...) * antecedents of other neurologic pathologies before the acquired lesion * oral or written comprehension dysfunctions.

Keywords: acquired cerebral lesion anger aggression
safety and efficacy study of herpes simplex virus type 2 (hsv-2) therapeutic dna vaccine

Conditions: Herpes Genitalis

Summary: the purpose of this trial is to evaluate the safety and efficacy of a therapeutic dna vaccine in adults with symptomatic herpes simplex virus type 2 (i.e., genital herpes).

to evaluate the safety and efficacy of 4 doses of vcl-hb01, a therapeutic hsv plasmid dna vaccine formulated with vaxfectin® in hsv-2-seropositive adults with a reported history of symptomatic genital herpes for at least one year.

Eligibility criteria:
inclusion criteria: * hsv-2 seropositive * a minimum of 1 year of reported history of genital herpes with recurrences. exclusion criteria: * history of receiving an investigational hsv vaccine * chronic illness for which a subject's immune system is suspected to be impaired or altered, such as cancer, autoimmune conditions, or diabetes * pregnant or breastfeeding

Keywords: hsv-2 genital herpes herpes herpes simplex virus, type 2
effects of combine ems and mirror therapy in upper limb stroke patients

Conditions: Stroke

Summary: this study will be designed to evaluate the effectiveness mirror therapy combined with electrical muscle stimulations compared with constraint induced therapy in upper limb stroke patients. the aim of the study is to investigate the therapeutic effectiveness of mirror therapy and ems in stroke patients and compare the outcomes with cimt.

stroke or cva is the sudden death of the brain cells due to inadequate blood flow, it's a focal disturbance of cerebral function, with symptoms lasting for 24hrs or longer or leading to death, with no apparent cause other than of vascular origin. the commonest consequence of stroke is loss of upper limb function. the protocol planned for improving the function of the upper limb is mirror therapy combined with ems and compare with constraint-induced movement therapy (cimt) treatment in stroke patients many works done on cimt and mirror therapy in rehabilitation prove to be powerful tools for upper limbs in people with stroke. different studies concluded that cimt is more effective than mirror therapy (mt) in the upper extremity in stroke patients. an rct was published in 2019 in which mirror therapy combined with electrical stimulation proves to be effective in stroke patients. however, i have not found a study comparing ems combined with mirror therapy compared to cimt treatment in stroke patients. according to the alternate hypothesis mirror therapy combined with ems has beneficial effects on clinical outcomes in upper limb stroke patients. according to the null hypothesis, cimt has better results in stroke patients as compared to ems combined with mirror therapy.

Eligibility criteria:
inclusion criteria: * both male and female stroke patients above 45 years * ischemic and haemorrhagic chronic stroke patients * participants should be able to do 100 wrist extension exclusion criteria: * patients with an implanted electrical device * patients with paresis * patients of hemiplegia caused due to other brain injuries (tbi, tumour), coordination problem * individuals with impaired sensory perception

Keywords: electrical muscle stimulation constraint induced movement therapy mirror therapy
lisa rigid catheter vs lisa soft catheter in a very preterm manikin

Conditions: Respiratory Distress Syndrome in Preterm Infants

Summary: less invasive surfactant administration (lisa) can be provided using rigid or soft catheters, but possible differences in terms of easiness of use and success of the procedure are unknown. a difficult procedure may have some drawbacks such as the prolonged duration of the laryngoscopy needed to insert the device, which is likely to aggravate the invasiveness of the procedure and result in stressful consequences such as bradycardia, hypoxia, and hemodynamic changes. objectives: i) time of device positioning, ii) success of the procedure of positioning the device, iii) participant's satisfaction.

this is an unblinded, randomized, controlled, crossover (ab/ba) trial of surfactant treatment with lisa with a rigid catheter vs. lisa with a soft catheter in a manikin simulating an extremely low birth weight infant. participants will be level iii nicu consultants and residents. randomization will be performed using a computer-generated random assignment list. the primary outcome measure will be the total time of device positioning. the secondary outcomes will be the success of the first attempt, the number of attempts to achieve the correct positioning of the device in the trachea, the achievement of the correct depth of the catheter in the trachea, and the participant's opinion on using the device.

Eligibility criteria:
inclusion criteria: * level iii nicu consultants and residents will be eligible to participate in the study exclusion criteria: * there are no exclusion criteria for this study
evaluation of a powered surgical stapler in video-assisted thoracoscopic lung resection procedures in korea

Conditions: Non-small Cell Lung Cancer (NSCLC)

Summary: collection of real world outcomes of video-assisted thoracoscopic surgery (vats) for lung cancer (lobectomy, wedge resection) using echelon flex™ powered endopath® staplers 45 mm and/or 60 mm (study devices) in a korean population.

this clinical trial assessed the use of a powered stapler for transection in vats lung resection, where there is currently limited published clinical data. the primary study endpoint was occurrence and duration of air leak / prolonged air leak (pal). procedure details and perioperative outcomes associated with vats lung resections were also evaluated.

Eligibility criteria:
inclusion criteria: * suspected or confirmed of nsclc (up to and including stage ii), or individuals undergoing vats diagnostic wedge resection in accordance with their institution's standard of care (soc); * scheduled for lung resection surgery (lobectomy or wedge resection) involving only one lobe of the lung; * performance status 0-1 (eastern cooperative oncology group classification); * asa score ≤ 3; * no prior history of vats or open lung surgery; * willing to give consent and comply with study-related evaluation and treatment schedule; and * at least 19 years of age. exclusion criteria: * active (subject currently receiving systemic treatment) bacterial infection or fungal infection; * systemic administration (intravenous or oral) of steroids, including herbal supplements that contain steroids, (within 30 days prior to study procedure); * chemotherapy or radiation therapy for lung cancer may not be performed for 30 days prior to the procedure; * scheduled concurrent surgical procedure other than wedge resection or lobectomy (central venous access - e.g., port placement, mediastinoscopy with lymph node sampling, and vats lymphadenectomy are allowed); * pregnancy; * physical or psychological condition which would impair study participation; * the patient is judged unsuitable for study participation by the investigator for any other reason; or * unable or unwilling to attend follow-up visits and examinations.
a individualized physical function improvement program for frailty elderly using goal attainment scaling (gas) as evaluation method: protocol for a randomized controlled trial

Conditions: Elderly

Summary: frailty refers to the age-related decline in physiological functions，that is associated with adverse outcomes. frailty is a dynamic reversible state, that requires a comprehensive individualized management. goal attainment scaling (gas) is a structured, individualized method for setting and evaluating progress toward personalized goals. we conducted a randomized clinical trial of an individualized intervention program using gas as evaluation method designed to improve physical functional in frailty elderly. a total of 160 individuals aged ≥60 years, who fulfill the fried scale of frailty will be recruited from beijing chaoyang hospital, capital medical university. all participants set personalized goals through gas. patients in the intervention group receive individualized interventions, implement tailored measures based on personalized goals to reverse the frailty state.the participants will be followed-up for 3 months and 24 months. this protocol would be established to examine the efficiency of targeted individualized intervention for frailty based on the gas. if a positive consequence could be obtained, the results of this study will provide critical data for management of frailty in the elderly, that can be carried out in routine clinical practice.


Eligibility criteria:
the inclusion criteria were the following: (1)≥60-years old; (2) recognized as frailty by fried scale. the exclusion criteria were the following: (1) considered with life expectancy \< 1 year such as advanced cancer patients; (2) difficult to communicate with such as patients with severe cognitive impairment (mini mental state examination score ≤ 17); (3) severe hearing disord.
suitability of picc for transpulmonary thermodilution compared to cicc

Conditions: Peripherally Inserted Central Catheters; CVC; Transpulmonary Thermodilution; Hemodynamic Monitoring

Summary: peripherally inserted central catheters (piccs) are increasingly used in intensive care unit (icu) as an alternative to centrally inserted central catheters (ciccs) for intravenous infusion. in the present study we try to assess their reliability for measuring cardiac index (ci) with trans-pulmonary thermodilution (tptd) technique.


Eligibility criteria:
inclusion criteria: * adult patients (≥18 years) admitted to the icu * patients requiring hemodynamic monitoring using ev1000tm * patients having both picc and cicc in place (these patients had their picc replaced with a cicc, usually at the time of icu admission, or vice versa, usually at the end of their icu stay, and were enrolled immediately after the placement of the new device before the previous one was removed) exclusion criteria: * body weight \<40 kg * severe aortic regurgitation or intra-cardiac shunt * treatment with an intra-aortic balloon pump * contraindication for placement of picc, cicc or a femoral arterial catheter * abdominal aneurism * extracorporeal circulation * pregnancy * lack of informed consent

Keywords: picc shock cardiac output
trufill®'s line in intracranial aneurysm embolisation

Conditions: Aneurysms

Summary: the objective of this study is to evaluate the long term efficacy and safety of the codman trufill®'s line of coils in the treatment of patients with intracranial ruptured or non-ruptured aneurysms in real-life routine clinical practice.


Eligibility criteria:
inclusion criteria: * patient ≥ 18 years old * patient presenting one or more ruptured or non-ruptured intracranial aneurysms assessed by angiography * patient implanted with one or more codman trufill® coils * patient agree to take part in the study, or agreement of a representative of the patient in case of patient inability, after being informed by the investigator and have received information letter. exclusion criteria: * patient who does not accept to take part in the study after being informed * patient already enrolled in a clinical trial involving experimental medication or device.

Keywords: intracranial ruptured non-ruptured aneurysms intracranial ruptured or non-ruptured aneurysms